Kornimate/medical-research-clean huggingface dataset:
effect of lactobacillus gg on atopic march

Conditions: Cow's Milk Allergy; Atopic Disease

Summary: food allergy (fa), defined as an adverse immune response to food allergens, is among the most frequent allergic disorders in childhood and it has recognized as a major paediatric health problem due to the severity of the reactions and the dramatic increase over the past decades. cow's milk allergy (cma) is the most frequent fa in children worldwide, and it has been demonstrated that it could be the first manifestation of the so-called "atopic march", characterized by the occurrence of other allergic disorders in the subsequent years after the onset of cma. in a previous study, involving children with cma over a period of 5 years, 40% developed asthma, 21% atopic eczema, and 43% allergic rhinitis. similar results have been reported in a recent study on finnish children intestinal microflora appears to have a crucial role in the development of atopic disorders. children with atopic diseases have different commensal bacterial groups in the gut compared to non-atopic children, and differences are also found between countries with high and low incidence of atopic diseases. there is currently great interest in manipulating the normal microbiota to accrue health benefits through an approach known as "probiotics." probiotics are defined as "live microorganisms which when administered in adequate amounts confer a health benefit on the host". the conceptual basis of possible use of probiotics in the prevention and treatment of atopic disorders is well grounded. lactobacillus gg (lgg) is the most studied probiotic in the prevention and treatment of atopic disorders. wide and well-designed clinical studies have provided several evidences on the efficacy of lgg as preventive or therapeutic strategy in pediatric atopic disorders. more recently, in vitro studies have provided evidences on the potent immunoregulatory role and on the influence on intestinal microflora composition (toward a more beneficial composition in the prevention and treatment of atopic disorders) elicited by lgg. this view has been further reinforced by recent research showing that lgg is able to improve recovery of intestinal symptoms in infants with cma-induced allergic colitis.


Eligibility criteria:
inclusion criteria: * infants aged less than 12 months, with a diagnosis of cow's milk allergy exclusion criteria: * age higher than 12 months, * concomitant chronic systemic diseases, * congenital cardiac defects, * active tuberculosis, * autoimmune diseases, * immunodeficiency, * chronic inflammatory bowel diseases, * celiac disease, * cystic fibrosis, * metabolic diseases, * malignancy, * chronic pulmonary diseases, * malformations of the gastrointestinal tract, * suspected eosinophilic esophagitis or eosinophilic enterocolitis, * suspected food-protein-induced enterocolitis syndrome, * suspected cow's milk proteins-induced anaphylaxis
naroa study: national register of open abdomen

Conditions: Open Abdomen Technique

Summary: national register of open abdomen open abdomen procedure (observational and prospective study)

the open abdomen technique has widely been proven useful in the treatment of traumatic patients, but its indication in non-traumatic patients with catastrophic abdomen (peritonitis, ischaemia, pancreatitis) generates controversy. its heterogeneous implementation is based on insufficient evidence and originated in health systems very different from ours. its low prevalence imposes the need for a multicentre study. aims : establish a national, prospective, multi-centre national registry of non traumatic patients with open abdominal indication whether or not they undergo damage control surgery and open abdomen for: 1. describe in real time the indications, surgical technique, materials, time, risk factors, definitive closure, reinterventions and complications according to the clavien-dindo classification and mortality. 2. compare the results of the application or non-application of the open abdomen in non-traumatic patients between the different participating centers. 3. set the limits of the open abdomen in non-traumatic patients indication.

Eligibility criteria:
inclusion criteria: * indication to open abdomen in non-trauma patients * informed consent exclusion criteria: * open abdomen in trauma patients * no indication to open abdomen * informed consent refusal
a study of mm-121 in combination with chemotherapy versus chemotherapy alone in heregulin positive nsclc

Conditions: Non-Small Cell Lung Cancer; NSCLC; Adenocarcinoma; Heregulin

Summary: the purpose of this study is to determine whether the combination of mm-121 plus docetaxel is more effective than docetaxel alone in regards to pfs in patients with heregulin-positive nsclc.

this study is a randomized, open-label, international, multi-center, phase 2 study in patients with heregulin-positive nsclc histologically classified as adenocarcinoma that have progressed following no more than two systemic therapies for locally advanced or metastatic disease, one of which must have been a platinum containing regimen. all patients will initially be screened for heregulin status. eligible patients will be randomized to receive mm-121 in combination with docetaxel versus docetaxel alone.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of cytologically or histologically documented adenocarcinoma of the lung with either metastatic disease (stage iv), stage iiib or stage iiic disease not amenable to surgery with curative intent * not received more than 2 prior systemic therapies- one of which must have been a platinum based regimen- for primary or recurrent disease * tissue submitted for hrg-biomarker testing * ecog performance status (ps) of 0 or 1 exclusion criteria: * known alk mutation * presence of exon 19 deletion or exon 21 (l858r) substitution of the egfr gene * received \>2 prior systemic anti-cancer drug regimen for locally advanced disease * prior treatment with an anti-erbb3 antibody * ctcae grade 3 or higher peripheral neuropathy * symptomatic cns metastases or cns metastases requiring steroids * any other active malignancy requiring systemic therapy * clinically significant cardiac disease

Keywords: nsclc non-small cell lung cancer heregulin erbb3 docetaxel
prostatic urethral lift (pul) pre-/post-radiation treatment for prostate cancer

Conditions: Benign Prostatic Hyperplasia (BPH); Prostate Cancer

Summary: the purpose of this study is to test the use of the prostatic urethral lift (pul), urolift®, in prostate cancer (pca) participants seeking or undergoing radiotherapy for relief of urinary obstructive symptoms.

prostatic urethral lift (pul)/ urolift® is an fda-approved device for the treatment of obstructive symptoms due to benign prostatic hyperplasia (bph) (also called prostate gland enlargement). this study seeks to evaluate urolift's efficacy in a unique cohort of participants with obstructive symptoms who are candidates for radiotherapy or those who developed obstructive symptoms after radiotherapy. the primary objective of this study is to achieve urinary obstructive symptom relief in prostate cancer participants undergoing radiotherapy treatment with placement of pul. this will be quantified using primary effectiveness endpoints: * for pul placement post-ebrt and post-bt: ≥ 30% or ≥ 4 point international prostate symptom score (ipss) reduction 3 months after pul. * for pul placement pre-bt: ≥ 30% or ≥ 4 point ipss reduction 3 months after brachytherapy (bt) from pre-pul baseline. the team will also assess participant outcomes with regard to international prostate symptom score (ipss), peak urine flow (qmax),post-void residual (pvr), quality of life (qol) scores, benign prostatic hyperplasia impact index (bphii) scores, men's sexual health questionnaire (mshq) scores, and urinary incontinence at 6 and 12 months of pul placement post-external beam radiotherapy (ebrt), post-bt, and pre-bt.

Eligibility criteria:
inclusion criteria: * international prostate symptom score ≥ 12. * peak flow rate ≤ 12 ml/sec with at least 125 ml voided urine. * prostate volume ≤ 80 cc as measured either by trans-rectal ultrasound (us) or magnetic resonance imaging (mri). exclusion criteria: * obstructive median lobe of the prostate. * active urinary tract infection. * neurogenic non-obstructive voiding dysfunction. * obstructive symptoms secondary to prostate cancer (via cystoscopy). * patients with prior transurethral resection of the prostate (turp). * patients with prior history of urethral stricture.

Keywords: prostatic urethral lift (pul)
evaluation of the diagnostic performance of a bra prototype to detect breast cancer

Conditions: Breast Neoplasm Female

Summary: phi-bra is a prospective and monocentric pilot study to assess the diagnostic capability of an innovative bra prototype to detect breast cancer, compared to the current standard of care: the mammography. the phi-bra prototype is designed with sensors measuring different parameters simultaneously such as impedance and temperature. the bra will be tested on patients without breast lump (american college of radiology (acr) 1 et 2 birads classification) and with breast lump (acr 4b, c ou acr 5 birads classification). the aim of this pilot study is to compare the results obtained by phi-bra to the ones obtained by mammography. the phi-bra study is classified as clinical investigation category 4.4 based on the european union (eu) regulation (dm 2017/745).


Eligibility criteria:
inclusion criteria: * age between 18 and 75. * no breast cancer surgery background * bra size : s/m or m/l specific criteria for the "no breast lump" cohort: - negative mammography result (acr 1 a 2). specific criteria for the "breast lump" cohort: - suspicious breast lump discovered during the mammography (acr 4b ou c ou acr 5) and for which there is an indication of microbiopsy. exclusion criteria: * breast cancer background (surgery or radiotherapy) * breast lump classified as acr 3 ou acr 4a during the mammography

Keywords: breast cancer detection impedance
shock waves therapy combined with leg stretching in patients with plantar fasciitis

Conditions: Plantar Fascitis

Summary: the aim of this study is to evaluate the efficacy of a combination treatment consisting of eswt and stretching of different muscles in the lower body compared to eswt treatment alone in patients with plantar fasciitis.

background: plantar fasciitis is the most common cause of pain in the heel of the foot, manifested by the presence of pain in the antero-internal part of the calcaneus. currently, there is ample evidence of the efficacy of both shock waves and stretching in their treatment, however, no study has proven what results are obtained by combining the application of shock waves with stretching in different leg muscles. objectives: the main objective of the study is to compare the effects of oc treatment in conjunction with leg-length stretches against shock waves alone in reducing pain in patients with pf. the secondary objectives will be to observe the effects of both treatments on disability and activity limitation in both the short and medium term. materials and methods: a double-blind randomized clinical trial will be conducted. a total of 52 subjects (26 in each group) will participate in the study, divided into one group that will undergo shockwave therapy plus real stretching (experimental group) and another that will undergo shockwave therapy plus placebo stretching (control group). the primary variable of the study will be pain, and secondary variables will include changes in disability and activity limitation.

Eligibility criteria:
inclusion criteria: * presence of pain in the medial area of the sole of the foot lasting 3 or more months. * being diagnosed with plantar fasciitis by one of the physical therapists participating in the study. * have a pain level equal to or greater than 3 on the visual analogue scale (vas). exclusion criteria: * presence of bilateral plantar fasciitis. * signs of neurological abnormalities. * infections and malignant tumors. * history of presence of dysfunction in the lower extremity. * pregnant women * have been treated with shock waves in the previous 12 months.

Keywords: shockwave therapy stretching pain disability activity limitation
clinical efficacy and safety of compound methyl salicylate liniment

Conditions: Soft Tissue Injuries

Summary: this clinical trial program was established according to the ethical principles of the helsinki declaration and the gcp guiding principle, and a randomized grouping method was used to evaluate the efficacy and safety of compound methyl salicylate liniment in the treatment of acute and chronic soft tissue pain with a positive control drug, named diclofenac sodium liniment.

this study is a randomized, double-blind, parallel controlled multicenter clinical trial for evaluate the efficacy and safety of compound methyl salicylate liniment in the treatment of acute and chronic soft tissue pain with a positive control drug, named diclofenac sodium liniment. a total of 216 participants with acute or chronic tissue pain participated in this clinical trial. the clinical trial cases were equally allocated to each research center, and each center had 30-35 cases. the proportion of patients with acute soft tissue pain and chronic soft tissue pain was 1:1, and the proportion of the experimental group and the control group was 1:1.the observation index include self pain scale record, tenderness scale and swelling, the evaluation period was 7 days. the statistical analysis plan is prepared by the unit responsible for the statistics, and is prepared before the formal analysis of the data, and is discussed and identified at the blind audit meeting with the major researchers. statistical analysis will use sas8.2 statistical analysis software for data processing, and other statistical analysis plan to make detailed provisions. all the statistical tests were two-sided, and the value of p was less than or equal to 0.05, which would be considered statistically significant. measurement data use case number, mean, standard deviation, minimum, maximum, median and four sub spacing description, counting data and grade data use case number, percentage description.

Eligibility criteria:
inclusion criteria: * patients with various causes of acute and chronic soft tissue * local symptoms and signs include pain, swelling, bruising, tenderness, joint dysfunction; x-ray showed no fracture, dislocation, bone tumors and bone metabolism and open injury. exclusion criteria: * patients who do not belong to the scope of drug use * muscle, tendon, ligament and other soft tissue have broken completely * accompanied by skin damage or fracture, joint dislocation, bone tumor and metabolic bone disease local tissue damage * use of other drugs or therapies for the treatment of acute and chronic soft tissue pain after trauma * difficult to evaluate the effectiveness and safety of new drugs * severe hypertension, severe heart and lung dysfunction, severe arrhythmia, liver, kidney, hematopoietic system and other serious primary diseases, mental patients * pregnant women, lactating women * allergic constitution and allergic to the known components of the drug * participated in other clinical trials in the past month * use similar analgesics within a week * other researchers considered inappropriate patients to participate in the trial

Keywords: soft tissue, pain
c. difficile and ursodiol

Conditions: Diarrhea

Summary: in vitro findings have established that ursodeoxycholic acid is a surrogate for deoxycholic acid in preventing the growth of c. difficile, and interrupting recurrence. investigators will administer ursodeoxycholic acid for two months, beginning with metronidazole and/or vancomycin (8 to 10 days), antibiotics currently used for the treatment of acute c.difficile infection. ursodeoxycholic acid prevents c.difficile recurrence by (a) directly suppressing the growth of c. difficile and (b) permitting restoration of normal fecal bile acid composition (80% deoxycholic acid) to maintain growth suppression.

the non-investigational reference therapies, metronidazole, vancomycin and fidaxomicin , are fda-approved antibiotics currently in use today because of their effectiveness in suppressing the growth of c. difficile and therefore quickly eliminating the colitis and diarrhea. however, they do not promote the restoration of the normal bacterial flora. therefore, when medication is stopped, the c. difficile colitis returns. in vitro findings have established that ursodeoxycholic acid is a surrogate for deoxycholic acid in preventing the growth of c. difficile, and interrupting recurrence.

Eligibility criteria:
inclusion criteria: * male and female patients with recurrent c. difficile colitis * 18 years of age and older * capable of giving informed consent exclusion criteria: * patients with other gastrointestinal problems prone to cause diarrhea if they cannot be controlled for the period of the study. lactose intolerance or gluten enteropathy are not an exclusion provide that the potential subject is asymptomatic and can be expected to adhere to the appropriate dietary regimen. * patients with contraindications to metronidazole or vancomycin and/or ursodiol tablets or components of the formulations. * patients not available for long-term follow-up (2 months) by their physician will be excluded from the study.

Keywords: colitis bile
immune and genomic markers in alk+ nsclc

Conditions: Anaplastic Lymphoma Kinase Gene Translocation; Non-Small Cell Lung Cancer

Summary: the purpose of this research study is to obtain and study clinical history, and tissue and saliva specimens if available from participants with anaplastic lymphoma kinase-alk+ non-small lung cancer(nsclc)

the purpose of this study is to establish a registry of clinical data and tumor specimens of patients with advanced alk+ non-small lung cancer (nsclc) (defined as nsclc harboring an alk gene rearrangement). this will allow in-depth, comprehensive genomic and immunophenotypic analyses of alk+ tumors. together with the clinical data, these biologic specimens will enable the conduct of basic and translational research to identify genomic and immunologic markers associated with clinical outcomes for alk+ patients.

Eligibility criteria:
inclusion criteria: cohort 1 - alive individuals * men or women 18 years of age or the age of majority for their residential state of the united states, or older, at the time of consent. * histologically or cytologically confirmed advanced stage iiib-iiic not amenable to curative approach multi-modality (e.g., chemoradiation and/or surgery) treatment, or stage iv non-small cell lung cancer (nsclc) * demonstration of having advanced alk+ nsclc, as assessed by fluorescence in situ hybridization (fish), immunohistochemistry (ihc), next-generation sequencing (ngs) or circulating tumor dna analysis (ctdna). for alk fish, fusions must have been detected in at least 15% of tumor cells. * willingness to provide clinical and medical information to the study team as required. * willingness to provide archival tumor tissue, if available. patients may enroll even if no tumor tissue is available. * ability to read, write and communicate in english. * ability to sign a web-based informed consent form. cohort 2 - deceased individuals * deceased individuals diagnosed with advanced alk+ lung cancer at age 18 years or older may be studied on a case by case basis. inclusion will require availability of adequate archived tissue and release of tissue and records by next of kin, if available. exclusion criteria: * participants who are unwilling to provide informed consent. * participants who are younger than 18 years of age. * participants who are unable to comply with the study procedures. * known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements. * participants who have previously enrolled to the study.

Keywords: anaplastic lymphoma kinase gene translocation non-small cell lung cancer alk
a comparison of incisional negative-pressure wound therapy versus conventional dressings following abdominal surgery

Conditions: Abdominal Reconstruction

Summary: the purpose of this study is to compare outcomes between incisional negative-pressure wound vacuum-assisted closure (vac) therapy versus conventional dressings following abdominal surgery.

this study will prospectively compare rates of wound complications using incisional negative pressure wound therapy versus conventional dressings following abdominal reconstruction. patients will undergo abdominal surgery (panniculectomy, abdominoplasty, ventral hernia repair, or autologous flap reconstruction using abdominal donor tissue). following closure of the incision, patients will either have a gauze dressing placed over the incision (control group), or incisional vacuum-assisted closure (vac) therapy. the dressing will be removed over a time period of 2 to 5 days after surgery. the gauze dressing will be removed at 2 days and the wound vac will be removed at 5 days. after this time, the wound will be assessed for signs of infection, seroma, hematoma, skin and fat necrosis, skin dehiscence, and hernia during the follow-up appointments.

Eligibility criteria:
inclusion criteria: * patients included in this study are patients undergoing abdominal reconstruction, which includes panniculectomy, abdominoplasty, ventral hernia repair and patients undergoing autologous flap reconstruction using abdominal donor tissue. exclusion criteria: * patients will be excluded from study if they have an actively infected wound involving the incision, abdominal malignancy, a history of enteric fistula formation, or a bleeding disorder.

Keywords: abdominal reconstruction
prognostic counselling in palliative head and neck cancer (procopall)

Conditions: Squamous Cell Carcinoma of Head and Neck

Summary: the investigators test the effect of providing individualized prognostic information on life-expectancy to head and neck cancer patients in the palliative phase.

in this prospective sequential cohort study, the investigators aim to include 160 patients with a palliative diagnosis of head and neck squamous cell carcinoma, divided into two cohorts. in cohort 1, patients will receive general prognostic counselling, while in cohort 2, patients will receive individualized prognostic counselling using the recently developed prognostic model 'oncologiq palliative'. cohort 2 will commence after completion of cohort 1. the primary outcome will be decisional conflict and satisfaction with the decision-making process and proactive care planning. additionally, we will assess whether patients undergo palliative treatment and, if so, the type of treatment received. we will also evaluate overall survival, the incidence of palliative sedation or euthanasia, and quality of life.

Eligibility criteria:
inclusion criteria: * patients who received a palliative diagnosis of a squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, hypopharynx, supraglottic larynx, glottis larynx and unknown primary. exclusion criteria: * illiterate patients * insufficient knowledge of dutch language * incompetent (due to i.e. mental state) to consider their own treatment choice

Keywords: palliative care life expectancy counseling quality of life prognosis